CG Oncology, Inc. CGON
CG Oncology, Inc. (Nasdaq: CGON) is an oncology drug developer. Its lead program, Cretostimogene grenadenorepvec (cretostimogene), is in Phase 3 for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease. Its next catalyst on record is Cretostimogene BOND-003 Cohort C: BLA submission completion (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Cretostimogene BOND-003 Cohort C — BLA submission completion (Q4 2026). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Cretostimogene (BOND-003 Cohort C) | BCG-unresponsive NMIBC with CIS ± papillary disease | biologic-other | Phase 3 |
| Cretostimogene (PIVOT-006) | Intermediate-risk and high-grade Ta ≤3cm NMIBC | biologic-other | Phase 3 |
| Cretostimogene (BOND-003 Cohort P) | BCG-unresponsive papillary only NMIBC | biologic-other | Phase 2 |
| Cretostimogene (CORE-008 Cohort A) | BCG-naïve high-risk NMIBC | biologic-other | Phase 2 |
| Cretostimogene (CORE-008 Cohort B) | BCG-exposed high-risk NMIBC | biologic-other | Phase 2 |
| Cretostimogene + gemcitabine (CORE-008 Cohort CX) | BCG-exposed high-risk and BCG-unresponsive NMIBC | biologic-other | Phase 2 |
Recent results and decisions
- Feb 27, 2026positive BOND-003 Cohort P HG-EFS of 95.7%, 84.6% and 80.4% at 3, 6 and 9 months (SUO late-breaker, Dec 2025 re-presentation).
Cretostimogene demonstrated HG-EFS at 3- 6- and 9-months of 95.7%, 84.6% and 80.4%, respectively, in HR BCG UR Ta/T1 disease in BOND-003 Cohort P.
Filing - Jan 9, 2026positive Investor deck restates SUO 2025 Cohort P data: high-grade event-free survival 95.7% at 3 months, 84.6% at 6 months, 80.4% at 9 months.
BOND-003 Cohort P (HR BCG UR Ta/T1 Disease)2 95.7% (3-mo) HG-EFS 84.6% (6-mo) 80.4% (9-mo)
Filing - Nov 14, 2025submitted Rolling BLA submission to FDA initiated for cretostimogene monotherapy in HR BCG-unresponsive NMIBC; complete submission expected in 2026.
The Company initiated its rolling BLA submission for cretostimogene with complete submission expected in 2026.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
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- BioNTech SE BNTX
- Guardant Health, Inc. GH
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The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.